BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3021894 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04259
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, LOT# L72772, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER; PRODUCT ID 8709, LOT# L72772, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACTUAL RESIDUAL VOLUME OF 10 ML WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME OF 4 ML. THE PATIENT HAD COMPLAINED THAT THE PUMP HAD NOT BEEN AS EFFECTIVE RECENTLY IN CONTROLLING THEIR PAIN. THE PUMP LOGS DID NOT INDICATE ANY ISSUES, THUS THE PHYSICIAN PLANNED TO DO A DYE STUDY TO CHECK THE CATHETER. THE PUMP WAS DELIVERING FENTANYL, BUPIVACAINE, AND BACLOFEN. ADDITIONAL INFORMATION WAS PROVIDED THAT WHEN ATTEMPTING THE CATHETER DYE STUDY THROUGH THE CATHETER ACCESS PORT (CAP), THEY COULD NOT ASPIRATE MORE THAN A FEW DROPS OF DRUG. THE DYE STUDY WAS ABORTED AND A ROTOR STUDY WAS PERFORMED. THE RESULTS OF THE ROTOR STUDY CONFIRMED THAT THE PUMP WAS FUNCTIONAL AND MOVING, AND THE PUMP LOGS ALSO SUPPORTED THESE RESULTS. IT WAS NOTED THAT THE NEXT STEP WOULD BE A CATHETER REVISION OR REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123855 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention